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AADvac1, an investigational vaccine targeting abnormal tau protein, a hallmark of Alzheimer’s disease, was found to be safe and effectively reduced the signs of neurodegeneration in patients with mild disease, according to data from the ADAMANT Phase 2 clinical trial. In a subgroup of participants with a confirmed…

A new Phase 3 trial, a collaboration between Eli Lilly and the Banner Alzheimer’s Institute, is planned to evaluate the potential of donanemab in preventing  the cognitive and functional decline related to Alzheimer’s disease. Called TRAILBLAZER-ALZ 3, the study will enroll people with “evidence” of Alzheimer’s but no clinical symptoms.

Researchers have identified new mutations in six genes that may increase the risk of developing Alzheimer’s disease. Their study involved the genetic analysis of 19 families in Utah with higher-than-normal occurrence of the disease. The scientists found relevant mutations in the genes PELI3, FCHO1, SNAP91, COX6A2, MUC16, and PIDD1.

SciSparc is set to start a Phase 2a study evaluating the safety and efficacy of SCI-110, its investigational cannabinoid-based therapy for Alzheimer’s disease and agitation. “We are very excited to begin our trial,” Adi Zuloff-Shani, PhD, chief technologies officer of SciSparc, said in a press release, noting…

Alzamend Neuro has requested approval from the U.S. Food and Drug Administration (FDA) to begin clinical trials to test AL001, its investigational lithium-based ionic cocrystal oral therapy for dementia related to Alzheimer’s disease. The request was made in the form of an investigational new drug (IND) application that,…

The U.S. Food and Drug Administration (FDA) has pulled back the controversial and sweeping approval recently given to Aduhelm (aducanumab), updating the treatment’s label at its manufacturer’s request so that it is prescribed to early-stage Alzheimer’s patients only rather than all with this disease.

The University of Wisconsin School of Medicine and Public Health is recruiting participants for a Phase 3 trial that will test the efficacy and safety of lecanemab (BAN2401) in those who are at risk of developing symptoms of Alzheimer’s disease. The global AHEAD (NCT04468659) study seeks to…

Note: This story was updated July 7, 2021, to reflect that patients with two copies of the APOE4 gene are heterozygous and that the study will measure biomarkers in blood plasma. Patient enrollment is now complete for Alzheon’s Phase 2 clinical trial evaluating the effects of ALZ-801 on disease-related…

The U.S. Food and Drug Administration has named Eli Lilly’s donanemab a breakthrough therapy for treating Alzheimer’s disease, the company announced in a press release. Lilly said it intends to submit a biologics license application or BLA — which would allow it to market donanemab in the U.S.

Based on new evidence from an ongoing Phase 2b clinical trial, the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to lecanemab, also called BAN2401, an investigational antibody for treating early Alzheimer’s disease. The therapy, being developed jointly by Eisai and Biogen, is designed to…